Viral Conjunctivitis Treatment Study

Viral Conjunctivitis Clinical Trial

Official title:

Avenova for the Treatment of Viral Conjunctivitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03861728
• Other study ID #: 20170064
• Status: Terminated
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: February 8, 2020

Study information

• Verified date: November 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the efficacy Avenova® (0.01% hypochlorous acid) in the treatment of viral conjunctivitis. The investigators hypothesize that patients treated with Avenova® will have a quicker resolution of their ocular signs and symptoms of Viral Conjunctivitis compared with artificial tears.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: February 8, 2020
• Est. primary completion date: February 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting to the Bascom Palmer Eye Institute

• Clinical diagnosis of viral conjunctivitis

• Symptoms less than 1 week duration

Exclusion Criteria:

• history of allergic conjunctivitis

• history of herpetic eye disease

• concurrent diagnosis of bacterial conjunctivitis (based off microbiology plating)

• Immunocompromised / Immunosuppressed patients

• Patients with HIV

• pregnant women

• prisoners

• adults who are unable to provide consent

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Viral
• Viral Conjunctivitis

Intervention

Device:
• 0.01% Hypochlorous acid
Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)

Other:
• Placebo
Placebo to be used four times a day to the affected eye for 2 weeks

Locations

Country	Name	City	State
United States	University of Miami Bascom Palmer Eye Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	NovaBay Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Debabov D, Noorbakhsh C, Wang L, et al. Avenova™ with Neutrox™ (pure 0.01% HOCl) compared with OTC product (0.02% HOCl). NovaBay Pharmaceuticals, Inc., Emeryville, California, USA

Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon JH. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. doi: 10.1097/MLG.0b013e31817f4d34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Resolution of Viral Conjunctivitis	This is the number of participants who on day 7 (+/-1 days) had on clinical examination a 0 or 1 on the follicular conjunctivitis scale and 0 or 1 on the conjunctival injection scale.	Up to 8 days
Secondary	Number of Participants With Symptomatic Resolution of Viral Conjunctivitis	This is the number of participants who on day 7 (+/-1 days) answered on clinical questionaire "none" or "mild" to each of the following list of 7 symptoms: "overall symptoms that affect your daily activities", "itching", "tearing", "pain", "feeling that your lids are stuck together in the morning", "sensitivity to light", "blurry vision"	Up to 8 days
Secondary	Number of Participants With Undetectable Adenoviral DNA	This is the number of participants who on day 7 (+/-1 days) had undetectable adenoviral DNA by quantitative Polymerase Chain Reaction (qPCR) (Ct > 35)	Up to 8 days